Dr. Karolina Urban reports

AVICANNA ANNOUNCES MEDICAL CANNABIS REAL WORLD EVIDENCE RESULTS AND PUBLICATION

Avicanna Inc. has published results from an investigator-led medical cannabis real-world evidence (MCRWE) study conducted through the MyMedi.ca platform. The study was led by Dr. Hance Clarke, director of pain services at University Health Network (UHN), and has been published in the peer-reviewed Canadian Journal of Pain.

The prospective, observational study evaluated patient-reported outcomes among individuals with chronic pain receiving physician-authorized medical cannabis in routine clinical practice. The study reflects a health-care-provider-supervised model of medical cannabis use and was supported by multiple clinicians and medical institutions across Canada. The study was led by Dr. Clarke at the UHN and supported by several other clinicians and medical institutions.

"While the term 'medical cannabis' is widely used, this study specifically evaluated outcomes among patients using medical cannabis under the supervision of a health care provider," said Dr. Clarke, principal investigator and clinician at UHN. "Among chronic pain patients who remained on an authorized medical cannabis product at six months, improvements were observed in pain severity, pain interference and several health-related outcomes. These findings support the potential role of medical cannabis in selected patients as indicated by preliminary real-world data, while highlighting the importance of clinician involvement in monitoring efficacy, safety and ongoing patient outcomes."

Study results summary

The publication reports findings from a cohort of chronic pain patients enrolled in a prospective, observational study assessing patient-reported outcomes over a 24-week follow-up period. Outcomes were measured using validated assessment tools commonly employed in pain and mental health research.

The observational results demonstrated statistically significant improvements from baseline in measures of pain interference and pain intensity, as well as improvements in validated measures of anxiety, depressive symptoms and overall quality of life over the 24-week observation period. While the magnitude of change did not meet established minimal clinically important difference thresholds, the observed directional improvements are consistent with findings reported in existing real-world and clinical literature. The results underscore the need for further placebo-controlled randomized trials to better define optimal dosing strategies, formulations and routes of administration for medical cannabis. The full study is available in the Canadian Journal of Pain.

Scientific and clinical significance

"This first peer-reviewed publication from our real-world evidence platform represents an important milestone," said Dr. Karolina Urban, PhD, executive vice-president of scientific and medical affairs at Avicanna. "High-quality, prospective real-world data can play a critical role in complementing randomized clinical trials, informing clinical practice and supporting the responsible integration of cannabinoid-based medicines into evidence-based care. As regulatory frameworks evolve globally, physician-supervised models and rigorous data generation will be increasingly important to advancing the field."

Study background and continuing enrolment

The study was implemented through the MyMedi.ca platform and Avicanna provided patient support services and clinical and data infrastructure required for large-scale real-world evidence research. Avicanna's scientific and medical teams supported platform operations, education and data co-ordination without influencing clinical decision making or patient care.

The MCRWE study is continuing, with continued patient recruitment under the leadership of Dr. Clarke. Participants have been enrolled across seven Canadian provinces, with support from multiple medical institutions. The study is designed to evaluate patient-reported outcomes associated with medical cannabis use, including pain, sleep, anxiety, depression and epilepsy, using validated assessment tools over a 24-week follow-up period. Secondary objectives include the assessment of changes in concomitant medication use. Additional information regarding the MCRWE study is available on the MCRWE website. Inquiries may also be directed to the study co-ordinator at 416-340-4800 (extension 4251) or mcrwe@uhn.ca.

About Avicanna Inc.

Avicanna is a commercial-stage international biopharmaceutical company focused on the advancement and commercialization of cannabinoid-based products and formulations for the global medical and pharmaceutical market segments. Avicanna has an established scientific platform, including R&D and clinical development leading to the commercialization of more than 30 proprietary, evidence-based finished products and supporting four commercial-stage business pillars:

• Medical cannabis formulary (Rho Phyto): The formulary offers a diverse range of proprietary products, including oral, sublingual, topical and transdermal deliveries with varying ratios of cannabinoids, supported by continuing patient and medical community education. Rho Phyto is an established brand in Canada, currently available nationwide across several channels and expanding into new international markets.
• Medical cannabis care platform (MyMedi.ca): MyMedi.ca is a medical cannabis care platform formed with the aim to better serve medical cannabis patients' needs and enhance the medical cannabis patients' journeys. MyMedi.ca is operated by Northern Green Canada Inc. and features a diverse portfolio of products and bilingual pharmacist-led patient support programs. MyMedi.ca also provides specialty services to distinct patient groups such as veterans and collaborates with public and private payers for adjudication and reimbursement. MyMedi.ca provides educational resources to the medical community to facilitate the incorporation of medical cannabis into health care regimens.
• Pharmaceutical pipeline: Leveraging Avicanna's scientific platform, vertical integration and real-world evidence, Avicanna has developed a pipeline of proprietary, indication-specific cannabinoid-based candidates that are in various stages of clinical development. These cannabinoid-based candidates aim to address unmet needs in the areas of dermatology, chronic pain and various neurological disorders.
• Active pharmaceutical ingredients (Aureus Santa Marta): Active pharmaceutical ingredients supplied by the company's majority owned subsidiary, Santa Marta Golden Hemp SAS (SMGH), is a commercial-stage business dedicated to providing various forms of high-quality CBD (cannabidiol), THC (tetrahydrocannabinol) and CBG (cannabigerol) to the company's international partners for use in the development and production of food, cosmetics, medical and pharmaceutical products. SMGH also forms part of the company's supply chain and is a source of reliable input products for its consumer retail, medical cannabis and pharmaceutical products globally.

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